Transcription of Annex 5 - WHO
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Annex 5 - WHO
Annex 5. Guidance on good data and record management practices Background During an informal consultation on inspection, good manufacturing practices and risk management guidance in medicines' manufacturing held by the World Health Organization (WHO) in Geneva in April 2014, a proposal for new guidance on good data management was discussed and its development recommended. The participants included national inspectors and specialists in the various agenda topics, as well as staff of the Prequalification Team (PQT) Inspections. The WHO Expert Committee on Specifications for Pharmaceutical Preparations received feedback from this informal consultation during its forty-ninth meeting in October 2014.
such as creation, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record. An audit trail facilitates the reconstruction of the history of such events relating to the record regardless of its medium, including the “who, what, when and why” of the action.
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